HealthPack Updated Industry on ISO 11607

At HealthPack 2009, Nick Fotis, director of global packaging development for Zimmer, gave the audience an update on ISO 11607, "Packaging for Terminally Sterilized Medical Devices," and its supporting documents. Fotis serves as cochair of the U.S. subcommittee TAG to Technical Committee 198 of Working Group 7. He also serves as an Editorial Advisory Board member to PMP News.

Technical Information Report 22, AAMI's guidance for ISO 11607, has recently been reissued with two new annexes, Fotis reported.

The first, Annex J, was added to help healthcare professionals comply with the requirements of ISO 11607. "It is not widely recognized that the scope of this AAMI document on sterile packaging includes, in its scope statement, the fact that 11607 is applicable to industry, to hospitals, and other healthcare facilities and wherever medical devices are placed in sterile barrier systems and sterilized," Fotis explained in a separate interview. "In fact, there are some large hospitals with central supply areas that service several different institutions across a city or region. They sometimes look and act more like an industrial medical packaging facility than like a local community hospital."

Fotis said that TC198/WG7 found that many healthcare professionals in hospitals, dental offices, surgicenters, etc., are unfamiliar with the technical terminology used in the medical packaging field. "An introductory annex that doesn't rely on industry jargon, but rather lays out the requirements of producing good, sterile packages, is what was needed. The requirements are all still there-remember that TIRs are not standards but helpful guidance-but the wording and explanation is targeted to someone working in a hospital or other clinical environment."

Fotis credits Ramona Connor, a nurse (RN, MSN, CNOR) who serves as manager, standards and recommended practices, for AORN, with helping with the standard. Dianne Trudeau, a nurse in Vancouver, Canada, also provided input. And "Hal Miller [of Pace Solutions LLC] was instrumental in helping bridge the gap between terminology and practice," Fotis adds.

Annex K has also been added to address the concept of worst-case requirements. The Sterile Packaging Manufacturers Council (SPMC) identified some industry confusion over ISO 11607's worst-case statements and explained its interpretation under the Frequently Asked Questions (FAQ) section on the council's Web site, www.sterilizationpackaging.org. "The white paper was then built upon by the working group to develop the document we have today," Fotis explains. "The annex addresses worst-case configuration in terms of devices, in terms of the sterile barrier system, and in terms of the manufacturing process. As industry and healthcare users take the approach of justifying and validating worst case conditions, it makes the entire healthcare environment safer for all of us."

Fotis adds that in terms of worst-case devices, one first thinks about heavy, sharp, and large devices. However, "the establishment of the worst case must be thought through. Sometimes the worst-case device might be the smallest device, which would tend to rattle around inside of a large packaging system."

In terms of a worst-case package, manufacturers might be asking a thermoform supplier to intentionally run at the low end of thickness or temperature in order to produce a part that might be more prone to failure than one that is run at a nominal or ideal condition, Fotis notes. "In many cases, however, utilizing multiple lots or runs of packaging material will capture the representative variability and will ensure with a high degree of probability that a reasonable worst case package is captured."

Finally, in terms of worst-case process, notes Fotis, sealing a Tyvek/poly pouch at the lowest temperature is often thought of as a worst case, as it usually generated the lowest heat seal strength and therefore creates a situation in which, during distribution testing, the device might force the seal open. "The good packaging engineer must also consider the hottest temperature, too. This temperature might create a situation called "burn through" in which the package is actually over-sealed, he says. "The resulting closure is very weak and prone to fracture or failure, perhaps at forces even lower than the low temperature seal mentioned previously."

Lastly, it should be noted that ISO has approved a work item to bring AAMI TIR 22 to the ISO level, confirming the usefulness and international need for the document. A good portion of the new ISO guidance will be an elaboration and expansion of Annex J. This effort is being lead by Jackie Daly Johnson, the US co-chair of the AAMI working group and president of Beacon Converters Inc.

Fotis also explained that ISO 11607 will be updated in 2011 or 2012 and AAMI is now looking for input on any needed changes. One change will involve limiting the test methods listed in Annex B to only those that have precision and bias statements. Others may entail requiring statements about the risk of medical device reuse to be printed on packages and clarifying that performance testing is different from stability testing. Fotis urged medical device manufacturers with revision suggestions to visit www.aami.org and visit Committee Central to locate Working Group 7.